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Study to Determine the Effect of Food on the Absorption of an Oral Testosterone Undecanoate Formulation

Male Hypogonadism Clinical Trial

Official title:
Phase II Study of the Effect of Food With Various Levels of Fat on the Pharmacokinetics of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men

Clinical Trial Summary

The purpose of the study is to determine the effect of food with various amounts of fat on the absorption of an oral testosterone undecanoate formulation.

Clinical Trial Description

Pharmacokinetics will be evaluated after the following types of meals: very low fat, low fat, normal diet, high fat, and fasting. Subjects will have one dose of TU administered 30 minutes after the initiation of the meal. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00924612
Study type Interventional
Source Clarus Therapeutics, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date July 2010
View Details
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